Tekturna, Other Blood Pressure Medications Should Have Black Box Warning Says Watchdog Group

Overview: A consumer advocacy group has called on the U.S. Food and Drug Administration (FDA) to issue stronger warnings for several classes of blood pressure medications. According to a report in MedPage Today, the watchdog group Public Citizen petitioned the FDA to place black box warnings about the combined use of angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and Tekturna.

Public Citizen, a consumer advocacy group, says that the Tekturna and 18 other blood pressure medications should have black box warnings; The group petitioned the FDA, requesting that the new warnings caution against using the medications together

ACE inhibitors, ARBs and Tekturna are commonly taken in combination because it is thought to be more effective, but according to Public Citizen studies have disproved this notion and shown that the combination can pose side effects such as low blood pressure, kidney failure and dangerously high blood potassium levels

Last year, the ALTITUDE trials were stopped because of side effects from Tekturna

Product: Tekturna (aliskiren), also sold under the brand name Rasilez outside the US

Manufacturer: Novartis

Side Effects & Complications

Strokes

Heart attacks

Acute renal failure

Renal complications

Hyperkalemia (high levels of potassium)

Hypotension (low blood pressure)

Syncope

Group Says Combo Can Lead to Dangerous Side Effects

ACE inhibitors, ARBs classes of medications used to treat hypertension, or high blood pressure. Tekturna (aliskiren) is another blood pressure medication; it is also sold under the brand name Rasilez outside of the US. These medications are often prescribed together because it is thought that the combination of the drugs would more effective than any of the drugs individually. According to Public Citizen, however, “this theory has been unequivocally disproven in two large studies involving tens of thousands of patients with heart disease and diabetes that failed to show any clinical advantage of combination therapy. On the contrary, the studies showed a higher rate of several life-threatening side effects, such as low blood pressure, kidney failure and dangerously high blood potassium levels, in patients taking the drugs together compared with patients on only one of the medications.” Public Citizen is petitioning the FDA to place a black box warning on these medications to warn about the potentially side effects.

ALTITUDE Trials

Last December, Novartis stopped clinical studies known as the ALTITUDE trials, which were conducted to evaluate the effects of Tekturna on heart and kidney conditions in Type 2 diabetics. The trials were halted after a review committee noted side effects such as non-fatal stroke, renal complications hyperkalemia (high potassium) and hypotension (low blood pressure). In April, the FDA updated the safety label on Tekturna in patients who have diabetes or moderate renal impairment (GFR< 60 mL/min) taking ACE inhibitors or ARBs.